Roche Pharmacovigilance Inspection Results

The EMA finalized its review of medicines in a pharmacovigilance inspection of all medicines manufactured by Roche. The review was initiated following a routine pharmacovigilance inspection in early 2012.
Last year’s inspection identified some safety data that the company had failed to submit, and the EMA was keen to examine whether these further data had any impact on the balance of benefits and risks of these medicines. Included in this review were 19 centrally authorized medicines, as well as various medicines that have been nationally authorized.

“The assessment by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) of the impact of the additional data provided by Roche on the medicines concerned has not identified any important new safety concerns. The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” EMA pointed out. “Patients should continue to take these medicines as previously advised.”

The Agency’s Committee for Medicinal Products for Human Use (CHMP) agreed with the conclusions of the PRAC. However, as Roche continues to provide additional data as part of the obligatory follow-up, the company is required to ensure that these data are included and considered in their routine pharmacovigilance activities, including the periodic cumulative reviews of the benefits and risks of these medicines.